Status:
COMPLETED
SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
Lead Sponsor:
Biotie Therapies Inc.
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Massachusetts General Hospital
Conditions:
Parkinson's Disease Dementia (PDD)
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a s...
Detailed Description
This study includes a Screening Period of up to 6 weeks, a 16 week Treatment Period, and a 2 week Safety Follow Up Period. Final eligibility will be determined at the Baseline Visit. Eligible patient...
Eligibility Criteria
Inclusion
- Parkinson's Disease Dementia
- Patient has a routine caregiver
- Taking a stable cholinesterase inhibitor.
- Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive
Exclusion
- History of any significant neurologic or psychiatric disease other than PD
- Any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study
- Unpredictable motor fluctuations that would interfere with administering assessments
Key Trial Info
Start Date :
December 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2017
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02258152
Start Date
December 22 2014
End Date
October 3 2017
Last Update
April 19 2019
Active Locations (20)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
3
UC San Diego
La Jolla, California, United States, 92037
4
Parkinson's Disease & Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States, 33486